AAMI ST40 2004 RA 2018
$131.66
ANSI/AAMI ST40:2004/(R)2018 – Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities
| Published By | Publication Date | Number of Pages |
| AAMI | 2004 |
This recommended practice provides guidelines for dry heat sterilization in health care facilities. It covers functional and physical design criteria for work areas; staff qualifications, education, and other personnel considerations; sterilization processing procedures; installation, care, and maintenance of table-top dry heat sterilizers; and quality control. Definitions, a bibliography, and annexes providing supplementary information are also included.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI ST40:2004/(R)2018, Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities |
| 2 | Objectives and uses of AAMI standards and recommended practices Blank Page |
| 3 | Title page |
| 4 | AAMI Recommended Practice Copyright information |
| 5 | Contents |
| 8 | Glossary of equivalent standards |
| 10 | Committee representation |
| 12 | Foreword |
| 13 | Introduction: Need for this recommended practice |
| 15 | 1 Scope 1.1 General 1.2 Inclusions 1.3 Exclusions 2 Definitions, symbols, and abbreviations |
| 17 | 3 Design considerations 3.1 General rationale |
| 18 | 3.2 Work area design and functional workflow 3.2.1 Definitions of work areas 3.2.2 Design criteria |
| 19 | 3.2.3 Functional workflow patterns 3.2.4 Traffic control 3.3 Physical facilities 3.3.1 Space requirements 3.3.2 Mechanical and electrical systems 3.3.3 General area requirements 3.3.3.1 Ceilings, floors, walls, and work areas |
| 20 | 3.3.3.2 Ventilation 3.3.3.3 Temperature and humidity 3.3.3.4 Lighting |
| 21 | 3.3.3.5 Handwashing facilities 3.3.4 Special area considerations 3.3.4.1 Decontamination |
| 22 | 3.3.4.2 Preparation and assembly 3.3.4.3 Sterilization 3.3.4.4 Sterile storage 3.4 Housekeeping 4 Personnel considerations 4.1 General rationale 4.2 Qualifications |
| 23 | 4.3 Training and continuing education 4.4 Health and personal hygiene 4.5 Attire 4.5.1 General |
| 24 | 4.5.2 Decontamination area |
| 25 | 4.6 Standard/transmission-based (enhanced) precautions 5 Processing recommendations 5.1 General rationale |
| 26 | 5.2 Receiving 5.2.1 General considerations 5.2.2 Newly purchased reusable items and repaired reusable items 5.2.3 Disposable items 5.3 Disposition of sterile items (issued but not used) 5.4 Handling, collection, and transport of items previously used in patient care |
| 27 | 5.5 Cleaning and other decontamination processes 5.5.1 General considerations |
| 28 | 5.5.2 Presoaking 5.5.3 Sorting and disassembly 5.5.4 Cleaning 5.5.4.1 General |
| 29 | 5.5.4.2 Cleaning agents 5.5.4.3 Methods of cleaning 5.5.4.3.1 Selection of an appropriate method 5.5.4.3.2 Manual cleaning |
| 30 | 5.5.4.3.3 Mechanical cleaning 5.5.4.4 Instrument cleaning 5.5.4.5 Utensil cleaning |
| 31 | 5.5.4.6 Verification of cleaning effectiveness 5.5.5 Microbicidal processes 5.6 Selection of packaging materials |
| 32 | 5.7 Sterilization of packaged items 5.7.1 Preparation of items to be sterilized 5.7.2 Loading the sterilizer 5.7.3 Equipment operation |
| 33 | 5.7.4 Sterilization cycle parameters 5.7.5 Unloading the sterilizer 5.7.5.1 Removing items from the sterilizer 5.7.5.2 Cooling 5.7.5.3 Handling and inspection 5.7.6 User safety factors |
| 34 | 5.7.7 Common operator errors 5.8 Sterilization of unwrapped items 5.8.1 General considerations 5.8.2 Preparation of unwrapped items 5.8.3 Cycle parameters for unwrapped items 5.8.4 Unloading the sterilizer 5.9 Sterile storage of packaged items 5.9.1 Dust covers |
| 35 | 5.9.2 Storage environment 5.9.3 Storage shelving 5.9.4 Shelf life 5.10 Distribution 5.10.1 Handling and inspection |
| 36 | 5.10.2 Distribution containers and cassettes 6 Installation, care, and maintenance of sterilizers 6.1 General rationale 6.2 Instruction manuals 6.3 Installation 6.4 Routine care and maintenance |
| 37 | 6.5 Repair and component replacement 6.6 Calibration 6.7 Recordkeeping 7 Quality control 7.1 General rationale |
| 38 | 7.2 Product identification and traceability 7.2.1 Lot control numbers 7.2.2 Sterilizer records 7.2.3 Expiration dating 7.3 Physical monitoring 7.3.1 Use of physical monitors |
| 39 | 7.3.2 Sterilizer malfunction 7.4 Chemical indicators 7.4.1 Definition 7.4.2 Selecting chemical indicators |
| 40 | 7.4.3 Using chemical indicators 7.4.3.1 External chemical indicators |
| 41 | 7.4.3.2 Internal chemical indicators 7.4.3.2.1 Placement and frequency of use 7.4.3.2.2 Retrieval and interpretation 7.4.3.2.3 Nonresponsive or inconclusive chemical indicators 7.5 Biological indicators 7.5.1 Definition 7.5.2 Selecting biological indicators 7.5.3 Frequency of use of biological indicators |
| 42 | 7.6 Sterilizer efficacy testing 7.6.1General considerations 7.6.2Construction of the PCD 7.6.3Placement of the PCD |
| 43 | 7.6.4Test procedure 7.6.5Acceptance criteria 7.6.5.1Qualification testing 7.6.5.2Routine biological monitoring 7.6.6Positive BI results |
| 44 | 7.6.7Microbiological testing 7.6.7.1General considerations 7.6.7.2Test procedure 7.6.7.3Interpretation of results 7.7 Periodic product monitoring 7.8 Product recalls 7.8.1 Policies and procedures 7.8.2 Recall procedure 7.8.3 Recall order |
| 45 | 7.8.4 Recall report 7.9 Third-party services |
| 46 | Annex A The science of dry heat sterilization A.1 Historical perspective on dry heat sterilization A.2 How dry heat (heated air) sterilization is accomplished A.3 Types of dry heat sterilizers |
| 49 | A.4 Variables associated with the dry heat sterilization process A.5 How dry heat sterilization is measured A.5.1 Microbial destruction A.5.2 Indirect measurement A.5.3 Direct measurement A.6 Typical items sterilized by dry heat |
| 50 | Annex B User verification of cleaning processes B.1 General considerations |
| 51 | B.2 Markers |
| 52 | B.3 Cleaning verification tests for users |
| 55 | Annex C Example of documentation of premature release of implants |
| 57 | Annex D Bibliography |
